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PROGRAF CONCENTRATE FOR is a brand name for Tacrolimus. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
Verbatim from this product's MHRA label. Tap a section to expand.
Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
General considerations The recommended initial dosages presented below are intended to act solely as a guideline. Prograf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations).
If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered. Prograf can be administered intravenously or orally. In general, dosing may commence orally; if necessary, by administering the capsule contents suspended in water, via nasogastric tubing.
Prograf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The Prograf dose may vary depending upon the immunosuppressive regimen chosen. g. morning and evening). Administration should commence approximately 12 hours after the completion of surgery.
05 mg/kg/day should be initiated as a continuous 24-hour infusion. g. morning and evening). 05 mg/kg/day should be administered as a continuous 24-hour infusion. Dose adjustment during post-transplant period in adults and children Prograf doses are usually reduced in the post-transplant period.
It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to Prograf monotherapy. Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Rejection therapy – adults and children Increased Prograf doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. g. 8) the dose of Prograf may need to be reduced.
For conversion to Prograf, treatment should begin with the initial oral dose recommended for primary immunosuppression. For information on conversion from ciclosporin to Prograf, see below under “Dose adjustments in specific patient populations”.
The adverse drug reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medications. Many of the adverse drug reactions stated below are reversible and/or respond to dose reduction.
Oral administration appears to be associated with a lower incidence of adverse drug reactions compared with intravenous use. Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Infections and infestations As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). The course of pre-existing infections may be aggravated.
Both generalised and localised infections can occur. Cases of CMV infection, BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Prograf.
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies. Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders, skin malignancies and Kaposi’s sarcoma have been reported in association with tacrolimus treatment.
4 under Excipients). Endocrine disorders rare: hirsutism Metabolism and nutrition disorders very common: hyperglycaemic conditions, diabetes mellitus, hyperkalaemia common: hypomagnesaemia, hypophosphataemia, hypokalaemia, hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, metabolic acidoses, hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, other electrolyte abnormalities uncommon: dehydration, hypoproteinaemia, hyperphosphataemia, hypoglycaemia Psychiatric disorders very common: insomnia common: anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders uncommon: psychotic disorder Nervous system disorders very common: tremor, headache common: seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders uncommon: coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia rare: hypertonia very rare: myasthenia not known: posterior reversible encephalopathy syndrome (PRES) Eye disorders common: vision blurred, photophobia, eye disorders uncommon: cataract rare: blindness not known: optic neuropathy Ear and labyrinth disorders common: tinnitus uncommon: hypoacusis rare: deafness neurosensory very rare: hearing impaired Cardiac disorders common: ischaemic coronary artery disorders, tachycardia uncommon: ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations rare: pericardial effusion very rare: Torsades de pointes Vascular disorders very common: hypertension common: haemorrhage, thromboembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders uncommon: infarction, venous thrombosis deep limb, shock Respiratory, thoracic and mediastinal disorders common: dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations uncommon: respiratory failures, respiratory tract disorders, asthma rare: acute respiratory distress syndrome Gastrointestinal disorders very common: diarrhoea, nausea common: gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms uncommon: ileus paralytic, acute and chronic pancreatitis, gastrooesophageal reflux disease, impaired gastric emptying rare: subileus, pancreatic pseudocyst Hepatobiliary disorders common: cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis rare: hepatic artery thrombosis, venoocclusive liver disease very rare: hepatic failure, bile duct stenosis Skin and subcutaneous tissue disorders common: pruritus, rash, alopecias, acne, sweating increased uncommon: dermatitis, photosensitivity rare: toxic epidermal necrolysis (Lyell’s syndrome) very rare: Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders common: arthralgia, muscle spasms, pain in extremity, back pain uncommon: joint disorders rare: mobility decreased Renal and urinary disorders very common: renal impairment common: renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms uncommon: anuria, haemolytic uraemic syndrome very rare: nephropathy, cystitis haemorrhagic Reproductive system and breast disorders uncommon: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common: asthenic conditions, […]
During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered. 5). CYP3A4 inhibitors Concomitant use with CYP3A4 inhibitors may increase tacrolimus blood levels, which could lead to serious adverse reactions, including nephrotoxicity, neurotoxicity and QT prolongation.
It is recommended that concomitant use of strong CYP3A4 inhibitors (such as ritonavir, cobicistat, ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin or josamycin) with tacrolimus should be avoided.
If unavoidable, tacrolimus blood levels should be monitored frequently, starting within the first few days of coadministration, under the supervision of a transplant specialist, to adjust the tacrolimus dose if appropriate in order to maintain similar tacrolimus exposure.
Renal function, ECG including the QT interval, and the clinical condition of the patient should also be closely monitored. Dose adjustment needs to be based upon the individual situation of each patient. 5). Similarly, discontinuation of CYP3A4 inhibitors may affect the rate of metabolism of tacrolimus, thereby leading to subtherapeutic blood levels of tacrolimus, and therefore requires close monitoring and supervision of a transplant specialist.
CYP3A4 inducers Concomitant use with CYP3A4 inducers may decrease tacrolimus blood levels potentially increasing the risk of transplant rejection. It is recommended that concomitant use of strong CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine), with tacrolimus should be avoided.
Hypersensitivity to tacrolimus or other macrolides. 1 - in particular polyoxyethylene hydrogenated castor oil or structurally related compounds.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. morning and evening). Administration should commence within 24 hours after the completion of surgery. 10 mg/kg/day should be initiated as a continuous 24-hour infusion. g. morning and evening). 100 mg/kg/day should be administered as a continuous 24-hour infusion.
Dose adjustment during post-transplant period in adults and children Prograf doses are usually reduced in the post-transplant period. It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to Prograf-based dual-therapy.
Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments. Rejection therapy – adults and children Increased Prograf doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
g. 8) the dose of Prograf may need to be reduced. For conversion to Prograf, treatment should begin with the initial oral dose recommended for primary immunosuppression. For information on conversion from ciclosporin to Prograf, see below under “Dose adjustments in specific patient populations”.
Dosage recommendations - Heart transplantation Prophylaxis of transplant rejection – adults Prograf can be used with antibody induction (allowing for delayed start of Prograf therapy) or alternatively in clinically stable patients without antibody induction.
g. morning and evening). Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised. 02 mg/kg/day should be initiated as a continuous 24-hour infusion. An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
g. renal dysfunction). In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids. Prophylaxis of transplant rejection – children Prograf has been used with or […]
If unavoidable, tacrolimus blood levels should be monitored frequently, starting within the first few days of coadministration, under the supervision of a transplant specialist, to adjust the tacrolimus dose if appropriate, in order to maintain similar tacrolimus exposure.
5). Similarly, discontinuation of CYP3A4 inducers may affect the rate of metabolism of tacrolimus, thereby leading to supratherapeutic blood levels of tacrolimus, and therefore requires close monitoring and supervision of a transplant specialist.
P-glycoprotein Caution should be observed when co-administering tacrolimus with drugs that inhibit P-glycoprotein, as an increase in tacrolimus levels may occur. Tacrolimus whole blood levels and the clinical condition of the patient should be monitored closely.
5). Herbal preparations Herbal preparations containing St. 5). 5). 5). 5). Vaccination Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective. The use of live attenuated vaccines should be avoided.
Nephrotoxicity Tacrolimus can result in renal function impairment in post-transplant patients. Acute renal impairment without active intervention may progress to chronic renal impairment. Patients with impaired renal function should be monitored closely as the dosage of tacrolimus may need to be reduced.
5). Concurrent use of tacrolimus with drugs known to have nephrotoxic effects should be avoided. When co-administration cannot be avoided, tacrolimus trough blood level and renal function should be monitored closely and dosage reduction should be considered if nephrotoxicity occurs.
Gastrointestinal disorders Gastrointestinal perforation has been reported in patients treated with tacrolimus. As gastrointestinal perforation is a medically important event that may lead to a life- threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea. Cardiac disorders Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions.
Most cases have been reversible, occurring primarily in children with tacrolimus blood trough concentrations much higher than the recommended maximum levels. Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic […]